FDA recall D-1350-2015

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals · Class III · drug

Product

AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50

Reason for recall

Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.

Distribution

U.S. Including: OH

Key facts

Status: Terminated
Initiation date: 2015-08-13
Report date: 2015-08-26
Termination date: 2015-08-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Huntsville, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1350-2015